An early intervention with low-dose aspirin in asymptomatic diabetic subjects attenuates progression of atherosclerosis, by decreasing inflammation and coagulation.
ID
Bron
Verkorte titel
Aandoening
Diabetes Mellitus type 2, no cardiovascular disease.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Markers of vascular wall inflammation, represented by hsCRP and Il-6.
Achtergrond van het onderzoek
The DIASP study is a study with a prospective, randomised, placebo controlled, double blind, crossover study design, concerning the effects of aspirin (ASA) on markers of inflammation and coagulation in subclinical atherosclerosis in type 2 diabetic subjects. At random, forty patients will receive aspirin in low or intermediate dose in one period and placebo in the other period.
Doel van het onderzoek
An early intervention with low-dose aspirin in asymptomatic diabetic subjects attenuates progression of atherosclerosis, by decreasing inflammation and coagulation.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Subjects will be randomised between aspirin 100 mg and 300 mg. During the study period, each group will be followed 16 weeks. Treatment with aspirin (100 or 300 mg) or placebo for 6 weeks will be followed by a washout period of 4 weeks. After the washout period, patients will be treated by placebo when they received aspirin during the first period, and aspirin when they received placebo.
Publiek
P.O. Box 9600
Marcel M.C. Hovens
Leiden 2300 RC
The Netherlands
+31 (0)71 5262085
Wetenschappelijk
P.O. Box 9600
Marcel M.C. Hovens
Leiden 2300 RC
The Netherlands
+31 (0)71 5262085
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Diabetes mellitus type 2;
2. Age >18 year;
3. HbA1c < 10%;
4. HsCRP >1.0 mg/l .
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. History of myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, proven manifest coronary artery disease, angina pectoris, heart failure or severe cardiac arrhythmia;
2. History of cerebrovascular accident, transient ischemic attack;
3. History of peripheral vascular disease, ankle/arm index < 1.0, history of partial ileal bypass surgery;
4. Uncontrolled hypertension;
5. Asthma;
6. Any bleeding disorder;
7. History of gastrointestinal tract bleeding;
8. Severe renal or hepatic dysfunction;
9. Pregnancy;
10. Recent participation in other research projects;
11. Recent blood donation;
12. Known allergy to salicylic acid;
13. Use of all NSAID’s;
14. Use of any antithrombotic medication;
15. Use of corticosteriods;
16. Use of HMG-CoA-reductaseinhibitors.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL267 |
| NTR-old | NTR305 |
| Ander register | : P03-154 |
| ISRCTN | ISRCTN84139732 |
Samenvatting resultaten
2. Diabetes Obes Metab. 2008 Aug;10(8):668-74. Epub 2007 Nov 22.